Firm

Recall of Zimmer Biomet spinal fusion stimulators

Several Zimmer Biomet Spinal Fusion Stimulators used to help surgeries were two or more bones of the spine are desired to be permanently connected, have been subject of a Class 1 recall by the U.S. Food and Drug Administration (FDA).

Class 1 recalls are the most serious type of recall, and it means using the device can be dangerous to the patient. It can cause serious injury or death.

Implants let harmful chemicals into the body

During the routine monitoring of the spinal implants, when biological tests are done to ensure compatibility of the device with the human body, the implants were found to have high levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity), according to the FDA’s reason for the recall.

The stimulator is used in spinal fusion surgery. It’s implanted on the patient’s back and provides constant electrical stimulation to the spinal cord.

The recall applies to Zimmer Biomet’s SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products. Specifically pertains to 33 units, with different serial numbers, distributed between March 28, 2017 and April 6, 2017, and manufactured between October 11, 2016 and January 18, 2017.

The higher than allowed cytotoxicity levels found during the company’s routine monitoring means it caused a toxic reaction in the body and can be destructive to cells.

According to the FDA, these stimulators potential harmful chemicals may cause the following complications:

Cytotoxicity

Chronic infections

A need for additional surgeries that can require extended hospital stays

Paralysis

And, in some cases, even death.

The device is meant to help in the healing of spinal fusion surgery, but instead was causing more pain and problems.

If you or a loved one recently had a spinal fusion stimulator surgically implanted in the back and have suffered side-effects, you may be eligible for compensation for pain, suffering, and medical bills.

Medical device manufacturers must put people over profit.

Zimmer has a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If the company failed to do this, it should be held responsible for injuries and the consequences of not warning the risks posed by their products or should have known of the problems.

At Greg Jones Law, we’re available to hold the manufacturer liable, to pay medical expenses, lost wages, pain and suffering and any permanent disability caused by these implants.

Greg Jones Law has the expertise and the resources to stand by patients and all affected by these spinal implants. We have a proven track record of helping victims of dangerous drugs and medical devices.

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